The Recall Desk
SevereFDA (Devices)·Z-2619-2026·Announced 2026-07-08

DSAEK Pack-RX surgical kits recalled for bacterial contamination

Windstone Medical Packaging is recalling 1,080 DSAEK Pack-RX surgical convenience kits containing Webcol Large Alcohol Prep Pads contaminated with Paenibacillus phoenicis bacteria discovered during a sterilization audit.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I. Per the rubric, FDA Class I recalls that do not meet Critical criteria (no reported deaths/serious injury) are scored as Severe (4).

Plain-English summary

Windstone Medical Packaging, Inc. is recalling DSAEK Pack-RX surgical convenience kits (Pack Number AMS12394B) distributed nationwide in Pennsylvania, Georgia, California, and Washington. The kits contain Webcol Large Alcohol Prep Pads that were recalled by Cardinal Health after the discovery of Paenibacillus phoenicis contamination during a routine sterilization dose audit. Approximately 1,080 kits are affected, identified by the following lot codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, and 241313.

Healthcare facilities that received these kits should stop using them immediately and contact Windstone Medical Packaging or Cardinal Health for instructions on product return or destruction.

The recalled product

Product
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kit
Hazard
Affected units
1,080

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI/DI none
  • Lot Codes: 237663
  • 237901
  • 237957
  • 238041
  • 238084
  • 238085
  • 238146
  • 238197
  • 238589
  • 239157
  • 239216
  • 239286
  • 239337
  • 239386
  • 239943
  • 240269
  • 240633
  • 240705
  • 240903

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · bacterial contamination

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